Duns Number:071595540
Device Description: SutureLoop Hi-Fi Suture, 20 inch Loop no. 2 (5 metric) White/Blue, Hi-FI Polyblend Suture, SutureLoop Hi-Fi Suture, 20 inch Loop no. 2 (5 metric) White/Blue, Hi-FI Polyblend Suture, Straight Needle
Catalog Number
HL200
Brand Name
SUTURE LOOP HI-FI
Version/Model Number
HL200
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K100006,K100006,K100006
Product Code
GAT
Product Code Name
SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
Public Device Record Key
89d6fe1b-5398-4f07-91aa-43ec29cedc4f
Public Version Date
December 04, 2020
Public Version Number
6
DI Record Publish Date
October 24, 2015
Package DI Number
20653405002052
Quantity per Package
12
Contains DI Package
10653405002055
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |